BARR LAUNCHES PLAN B OTC/RX DUAL-LABEL PRODUCT IN U.S.

Barr Pharmaceuticals announced that its Duramed Pharmaceuticals subsidiary has begun shipping the dual-label Plan B (levonorgestrel) emergency contraceptive OTC/Rx product. The product will be available in pharmacies across the U.S. by mid-November. The company also announced that the FDA has granted Duramed a three-year exclusivity for the product, based on clinical studies conducted for OTC approval.

Approved in August, the Plan B OTC/Rx dual-label product is an OTC product for consumers 18 and older and a prescription-only product for women 17 and younger, replacing the Plan B prescription-only product that has been marketed in the United States since 1999. Because Plan B remains a prescription product for some women, it is sold only in retail pharmacy outlets from behind the pharmacy counter and under the supervision of a pharmacist.

The company has implemented the Convenient Access, Responsible Education (CARE) program to provide information to pharmacists, physicians and other healthcare providers, as well as consumers, regarding the appropriate distribution, use and monitoring for compliance with prescription age requirements of Plan B OTC/Rx. The program also includes a comprehensive education program.